The objective of this open-label, exploratory study is to investigate the efficacy of BDNF Essentials® on cognition in a healthy adult population with self-reported memory complaints. As there is a dearth of available literature on BDNF in this study population, the current study is designed to understand the role of BDNF to inform potential future studies.
The objective of this open-label, exploratory study is to investigate the efficacy of BDNF Essentials® on cognition in a healthy adult population with self-reported memory complaints. As there is a dearth of available literature on BDNF in this study population, the current study is designed to understand the role of BDNF to inform potential future studies. The study population represents a target group of individuals who would benefit from safe and efficacious nutraceuticals for the support of cognitive function. This transitional stage from normal cognition to cognitive impairment is viewed as an opportune window for intervention. This population of participants is being recruited to expand on previously published work on these individual ingredients while limiting confounding variables that could influence outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Participants will take two capsules, twice daily with water for 84 days.
KGK Science Inc.
London, Ontario, Canada
Change in cognitive function
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory
Time frame: baseline to day 84
Change in cognitive function
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention
Time frame: baseline to day 84
Change in cognitive function
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing speed
Time frame: baseline to day 84
Change in cognitive function
Assessed by plasma Brain-Derived Neurotrophic Factor (BDNF) levels
Time frame: baseline to day 84
Change in plasma BDNF levels
Assessed using the Computerized Mental Performance Assessment System (COMPASS)
Time frame: baseline to day 28
Change in plasma BDNF levels
Time frame: baseline to day 56
Change in memory
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory
Time frame: baseline to day 28
Change in memory
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory
Time frame: baseline to day 56
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Change in attention
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention
Time frame: baseline to day 28
Change in attention
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention
Time frame: baseline to day 56
Change in processing speed
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing
Time frame: baseline to day 28
Change in processing speed
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing
Time frame: baseline to day 56
Change in mood
Assessed by the Profile of Mood States (POMS) score
Time frame: baseline to day 28
Change in mood
Assessed by the Profile of Mood States (POMS) score
Time frame: baseline to day 56
Change in mood
Assessed by the Profile of Mood States (POMS) score
Time frame: baseline to day 84
Change in Sleep
Assessed by the Sleep Quality Questionnaire score
Time frame: baseline to day 28
Change in Sleep
Assessed by the Sleep Quality Questionnaire score
Time frame: baseline to day 56
Change in Sleep
Assessed by the Sleep Quality Questionnaire score
Time frame: baseline to day 84
Change in Stress
Assessed by the Perceived Stress Scale Score
Time frame: baseline to day 28
Change in Stress
Assessed by the Perceived Stress Scale Score
Time frame: baseline to day 56
Change in Stress
Assessed by the Perceived Stress Scale Score
Time frame: baseline to day 84
Change in salivary cortisol levels
Time frame: baseline to day 84
Change in serum Interleukin (IL-6) levels
Time frame: baseline to day 84
Change in serum Tumour Necrosis Factor (TNF-alpha) levels
Time frame: baseline to day 84